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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE IMPACTION DRILL; DRIVER, WIRE, AND BONE DRILL, MANUAL
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STRYKER INSTRUMENTS-KALAMAZOO CORE IMPACTION DRILL; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number 5400300000
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/03/2014
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the core impaction drill was overheating.The procedure was completed successfully without a clinically significant delay; no medical intervention and no adverse consequences were reported.
 
Manufacturer Narrative
Updated with date of product return.
 
Event Description
It was reported that during a procedure at the user facility the core impaction drill was overheating.The procedure was completed successfully without a clinically significant delay; no medical intervention and no adverse consequences were reported.
 
Manufacturer Narrative
The device is available for evaluation but has not yet been received.Additional information may be submitted once the device is received and the quality investigation is complete.
 
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Brand Name
CORE IMPACTION DRILL
Type of Device
DRIVER, WIRE, AND BONE DRILL, MANUAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3967729
MDR Text Key4806580
Report Number0001811755-2014-02728
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5400300000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received08/19/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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